FDA Facility Registration with US Agent

Service Description – FDA Facility Registration with U.S. Agent

I provide FDA Facility Registration services with U.S. Agent representation for foreign food and cosmetic facilities that manufacture, process, pack, or hold products intended for the United States market.

This service is mandatory for facilities located outside the United States. Under FDA regulations, all foreign facilities must designate a U.S. Agent, who acts as the official point of contact between the FDA and the registered facility.

Who needs this service:

This service is required for:

• Foreign food facilities manufacturing, processing, packing, or holding food for human or animal consumption

• Foreign cosmetic manufacturers or processors subject to FDA facility registration requirements

If your facility is not physically located in the U.S., you are legally required to appoint a U.S. Agent.

What this service includes:

• FDA Facility Registration for food or cosmetic facilities

• New registration or update of an existing registration

• U.S. Agent representation

• Issuance of required identifiers, if not already available:

  • DUNS Number (for food facilities)

  • FEI Number (for cosmetic facilities)

• Review and validation of all registration data

• Submission through the official FDA system

• Ongoing availability as the FDA contact during the coverage period
  
  

⚠️ Important:
The U.S. Agent service fee is charged annually. This package covers the registration and one (1) year of U.S. Agent representation. Renewal is required to keep the registration compliant and active.

Information required from the client:

To complete the registration, the client must provide:

• Legal name of the company

• Complete foreign facility address (street, city, postal code, country)

• Mailing address (if different)

• Type of activity (manufacturing, processing, packing, holding)

• Product category (food or cosmetics)

• Responsible person’s full name, em@il, and ph0ne number

• Any existing FDA registration number (if applicable)

If the DUNS (food) or FEI (cosmetic) number is not available, I will handle the issuance as part of this service.

Timeline:

The typical processing time is 3 to 10 business days, depending on:

• Client responsiveness

• Processing time for DUNS number (food) or FEI number (cosmetics) issuance

Delays in providing required information may affect the timeline.

Important notes:

• This service covers one (1) facility per order;

• U.S. Agent services are renewed annually;

• Failure to maintain an active U.S. Agent may result in registration issues or FDA enforcement actions.